2018 Section 5 - Rhinology and Allergic Disorders

domains (time management, mental/interpersonal, output, and productivity loss) at all time points through 24 months. The Rhinosinusitis Symptom Inventory was used to determine the impact of standalone balloon dilation on various work and social metrics (work/school days missed, homebound days, physician/nurse visits, acute infections) (Table III). Data included results from over 160 patients. The mean reduction in each of these meas- ures from baseline to 12 months was highly significant ( P < .0001). This analysis also assessed the mean number of antibiotic courses in the 12 months before interven- tion compared to the 12 months after, and this difference was also markedly significant (4.5 vs. 1.6, P < .0001). Subgroup meta-analyses were performed to com- pare balloon dilation patients with CRS versus recurrent acute rhinosinusitis (RARS) and to compare patients with versus without anterior ethmoid disease. All stud- ies with a 12-month follow-up were included in the sub- group analyses, with the exception that the BREATHE study was not included in the CRS/RARS analysis because patients were not differentiated by disease type for that study. At 12 months follow-up, both patients with CRS (N 5 191) and RARS (N 5 52) experienced stat- istically significant ( P < .0001) and clinically meaningful improvements in mean SNOT-20 scores, with no signifi- cant difference between groups. Likewise, at 12 months follow-up, patients with ethmoid disease (N 5 97) as well as those without (N 5 211) had statistically significant ( P < .0001) and clinically meaningful improvements over baseline but no significant difference between groups. Meta-analysis of Standalone Balloon Dilation Versus FESS As shown in Figure 4, the mean SNOT-20 scores were highly consistent across the five single-arm stand- alone balloon dilation studies, the REMODEL balloon arm, and the REMODEL FESS arm. The mean change in SNOT-20 scores from baseline was significantly

Fig. 2. Meta-analysis of standalone balloon dilation studies: ran- dom effects model for mean SNOT-20 overall score and subscale scores over time. SNOT-20 5 20-item Sino-Nasal Outcomes Test.

and sphenoid disease were exclusion criteria in the REMODEL trial. Overall revision rates at 18 months were 2.7% (1/37) and 6.9% (2/29) in the balloon and FESS arms, respectively, and not significantly different. The complication rate remained at 0% for both treat- ment arms up to 24 months. Meta-analysis of Standalone Balloon Dilation Studies The number of treated patients available for the various outcome measures included in the meta-analysis are summarized by study in Table II. Demographic and baseline characteristics were compared across the stand- alone balloon dilation studies and demonstrated no sig- nificant differences between the study populations with respect to age, sex, asthma status, smoking history, or allergies. The pooled technical success rate for the six studies was 97.5% (825/846 sinuses). In the random- effects model, both the overall mean SNOT-20 change and mean subscale changes from baseline were signifi- cantly improved and clinically meaningful at all follow- up time points (Fig. 2). When examining the pooled standalone balloon dila- tion data with regard to recovery outcomes; 12.7% (21/ 166) complained of nausea and 13.8% (32/232) reported nasal bleeding. Prescription pain medications were taken for a mean (standard deviation) of 0.8 (1.3) days and over-the-counter pain medication for 1.5 (2.7) days. The mean recovery time was 1.4 (1.3) days, and mean procedural pain score was 2.6 (2.3) on a scale from 0 to 10, where 0 reflected no pain and 10 the worst conceiva- ble pain. The number of postoperative debridements per patient averaged 0.16 (0.55). Data from the WLQ were collected for employed patients for two of the studies and analyzed using a random-effects model (Fig. 3). Statistically significant improvements from baseline were observed in 4 of the 5

Fig. 3. Meta-analysis of standalone balloon dilation studies: random effects model for Work Limitations Questionnaire (WLQ) over time.

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